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The FDA has alerted Puerto Rican healthcare providers and facilities not to use Customed’s convenience packs and trays for surgical procedures. Read More
The FDA has hired a team of tough new investigators to crack down on medical devicemakers whose software doesn’t measure up in terms of verification and validation (V&V). Read More
A lack of documented testing of updated instructions for use for cleaning a heater-cooler system has helped earn LivaNova an FDA warning letter. Read More
Following a rash of infections related to duodenoscopes, the FDA has given its blessing to Fujifilm Medical Systems’ updated manual reprocessing instructions for its ED-530XT model. Read More
CrystalBraces has received an FDA warning letter for failing to adhere to several procedural and validation requirements for a dental aligner. Read More
ECRI Institute is raising safety concerns associated with medical devices ranging from flexible endoscopes to ventilators, calling for an increased awareness of hazards that the products pose to patients. Read More
A Senate report that followed an investigation by Sen. Patty Murray’s (D-Wash.) office has found that the FDA’s regulatory system for monitoring the safety of devices failed to quickly identify and resolve the spread of antibiotic-resistant infections linked to duodenoscopes. Read More